Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat (ENT) and Maxilla-Facial Surgery - A Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)
研究概览
简要总结
Our primary aim is to determine whether licorice gargling provides meaningful analgesia after oral surgery. Specifically, we propose to test the primary hypothesis that gargling with licorice solution reduces pain after oral surgery more than gargling with sugar water. Because effective analgesia can reduce pain and/or opioid consumption, we will jointly evaluate verbal response pain scores and overall morphine consumption considering licorice to be beneficial only if it proves non-inferior on both measures and superior on at least one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma
- •Anticipated extubation in the operating room
- •American Society of Anesthesia physical status 1-3
排除标准
- •Rapid Sequence Induction
- •Known or suspected allergy to licorice or its ingredients
- •Liver failure with bleeding disorders
- •Insulin-dependent diabetes mellitus
- •Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery
- •Chronic opioid use
- •Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump
- •superinfected oropharyngeal tumors
- •Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)
结局指标
主要结局
joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)
时间窗: first 2 postoperative hours
A joint outcome of average pain score and total opioid consumption between the end of surgery and the first two postoperative hours. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.
次要结局
- joint - pain scores and opiate consumption on day of surgery(from end of surgery until the morning of Post-Operative Day (POD) 1)
- joint - pain scores and analgesic consumption(from surgery conclusion to Post-Operative Day (POD) 3)
- postoperative coughing(first 2 postoperative hours)
研究者
Olga Plattner
Ao. Univ. Prof., Head of ophthalmologic anesthesia
Medical University of Vienna